ABSTRACT
Gatifloxacin is a broad spectrum fluoroquinolone that offers enhanced Gram-positive activity and anaerobic coverage to other fluoroquinolones. The pharmacokinetic parameters (Cmax, AUCo-t, tmax) of this drug have been evaluated to compare the single dose (400mg) bioavailability of gatifloxacin with the reference formulation. High performance liquid chromatography (HPLC) coupled with U-V detector set at 290 nm has been used to determine plasma concentration of 12 human volunteers as per DCGI (Drug Controller General of India) guidelines. The method has been validated over a linear range of 0.25 to 8 microg/ml from plasma. The minimum quantifiable concentration has been set at 0.25 microg/ml (% CV < 10%). The pharmacokinetic parameters are: Cmax = 4.366 +/- 0.44 microg/ml at tmax = 1.83 +/- 0.44 hour, AUCO0-t = 25.26 +/- 2.91 microg hour/ml, AUCo-inf = 33.68 +/- 4.31 microg hour/ml, Kel = 0.094 +/- 0.024/hour and t1/2 = 8.0 +/- 1.92 hour.
Subject(s)
Administration, Oral , Adult , Area Under Curve , Biological Availability , Calibration , Chromatography, High Pressure Liquid , Cross-Over Studies , Fluoroquinolones/administration & dosage , HumansABSTRACT
The newly developed proton pump inhibitor rabeprazole sodium is expected to have beneficial effects in the treatment of peptic ulcer. The pharmacokinetic parameters (C(max), AUC(o-t), t(max)) of this drug have been evaluated to compare the single dose (20 mg) bioavailability of rabeprazole sodium with the standard reference. High performance liquid chromatography (HPLC) coupled with UV detector set at 280 nm has been used to determine plasma concentration of 12 human volunteers as per Drugs Controller General of India (DCGI) guidelines. The method has been validated over a linear range of 20-480 ng/ml from plasma. The minimum quantifiable concentration was set at 10 ng/ml [co-efficient of variance (CV) < 10%]. By comparing AUC(o-t) the relative bioavailability of test preparation has been found to be 100.88% of that of reference preparation.
Subject(s)
2-Pyridinylmethylsulfinylbenzimidazoles , Adenosine Triphosphatases/antagonists & inhibitors , Anti-Ulcer Agents/blood , Benzimidazoles/blood , Cross-Over Studies , Dose-Response Relationship, Drug , Humans , Male , Omeprazole/analogs & derivatives , Proton-Translocating ATPases/antagonists & inhibitors , Therapeutic EquivalencyABSTRACT
A convenient, sensitive and simple method for the determination of rofecoxib in human plasma is presented. The analytical technique is based on reversed phase high performance liquid chromatography coupled with UV detector (Knauer, Germany) set at 272 nm. The retention time of rofecoxib after recovery from plasma, was 8.9 minutes. The method has been validated over a linear range of 50-450 ng/ml from plasma. After validation the method was used to study the pharmacokinetic profile of rofecoxib in 6 healthy volunteers as per DCGI guidelines after administration of a single oral dose (50 mg). The extraction efficiency from plasma varied from 93.95-99.58%. The minimum quantifiable concentration was set at 50 ng/ml (% CV < 10%). The pharmacokinetic parameters were Cmax = 318.58 +/- 30.65 ng/ml at tmax = 2.66 +/- 0.25 hours, AUC0-t = 4007.88 +/- 438.32 ng hour/ml, AUC0-yen = 5454.66 +/- 822.29 ng hour/ml, Kel = 0.0433 +/- 0.0067/hour, and t1/2 = 16.36 +/- 2.89 hours.
Subject(s)
Area Under Curve , Chromatography, High Pressure Liquid , Cyclooxygenase Inhibitors/blood , Humans , Lactones/blood , Reference Standards , Reproducibility of Results , SulfonesABSTRACT
A cross-sectional survey was conducted upon 500 respondents, comprising of 250 adults and 250 children who did consume antibiotics in the previous three months. Data were analysed to determine the patterns of utilisation, compliance and awareness regarding antibiotic medication amongst a selected urban population at Kolkata. Antibiotic consumption without prescription was evident amongst 41.2% of adults in comparison to that of 8.4% in children (P < 0.01). Compliance to daily dosage was observed in 40.8% of adults in comparison to 82.8% in children (P < 0.01). Awareness pattern regarding antibiotics were reported to have been more in the children group (16.4%) while compared to the adults (8%). The knowledge regarding antibiotic resistance remained more or less similar in both the groups. The study concludes that high over the counter (OTC) sale and inadequate compliance to antibitotic medication needs further intervention approach towards information, education and communication (IEC) to all concerned.
Subject(s)
Adolescent , Adult , Anti-Bacterial Agents/therapeutic use , Chi-Square Distribution , Child , Cross-Sectional Studies , Drug Utilization/statistics & numerical data , Health Knowledge, Attitudes, Practice , Humans , India , Patient Compliance , Urban PopulationABSTRACT
An attempt has been made to look into the age at presentation, incidence and clinical presentation of 40 patients with spinal dysraphism. Thirteen cases of myelomeningocele and 11 cases of meningocele constituted the 'aperta' group and there were 16 'occulta' cases. Though among the 'aperta' cases male is to female ratio was 1:1, a marked male preponderance of 2.2:1 was seen among 'occulta' cases. First born child was found to be most frequently (44.50%) affected in the present series. Myelography remained a mainstay in deciding operation in 'occulta' cases. All 'aperta' cases and 11 out of 16 'occulta' cases were treated by operation. Regarding results of treatment, all cases with meningocele were fully cured, cases with myelomeningocele showed no improvement but further deterioration of the neurological status could be arrested. Hydrocephalus was associated in 8 out of 13 cases with myelomeningocele and ventriculoperitoneal (VP) shunt were instituted in all of them. Prognostic significance of presence of hydrocephalus was profoundly grave as was evident from the mortality rate (10%) in this series.